Cardiac Safety Assessment

An Earlier Look at QT Prolongation

In December 2014, the news of a technique for assessing QT/QTc from data captured during Phase I clinical trials was shared during the FDA-hosted Cardiac Safety Research Consortium (CSRC) meeting.

The study by the FDA and CSRC demonstrated that new cardiac technology allows for assessment as early as a First-In-Human trial. The methodology includes a significant increase in ECG data evaluation, use of improved algorithms for cardiac assessment and careful analysis of compound systemic exposure to create a powerful combination of maximal data points in a smaller clinical trial performed as part of a required early stage study.

De-risk drug candidates by providing a more precise indicator of arrhythmia liability prior to late stage development investment

Improved development package for licensing or further in-house development

Considerable time and cost savings if TQT waiver can be obtained

Experience the Difference

Vince & Associates Clinical Research is well positioned to support the current and potentially shifting guidance expected next year. The expertise of the technical staff at our state-of-the-art clinical pharmacology campus is key for the successful completion of these complex cardiac safety studies.

CSRC Member: Vince & Associates is a member of the Cardiac Safety Research Consortium (CSRC) and participates with industry leaders on key issues that impact cardiac safety, including alternative approaches to ICH E14 for the assessment of arrhythmia liability in early drug development.

High Precision QT analysis allows for TQT-like statistical power in smaller studies such as Single and Multiple Ascending Dose (SAD/MAD) trials

Potential elimination of the traditional TQT study for some drugs if the early trial is scientifically rigorous and adequately designed; provides preparatory information for cases where the TQT study will need to be completed.

ECG & Holter Evaluation

Traditional ECG monitoring

High-Precision QT for interval evaluation

Industry-validated Dynamic QT beat-to-beat approach for early QT studies performed in traditional Phase I studies